Cognitive effects of estradiol after menopause: A randomized trial of the timing hypothesis
Conclusions:
Estradiol initiated within 6 years of menopause does not affect verbal memory, executive functions, or global cognition differently than therapy begun 10+ years after menopause. Estradiol neither benefits nor harms these cognitive abilities regardless of time since menopause.
Classification of evidence:
This study provides Class I evidence that estradiol initiated within 6 years of menopause does not affect cognition at 2.5 years differently than estradiol initiated 10+ years after menopause. (Source: Neurology)
Source: Neurology - August 14, 2016 Category: Neurology Authors: Henderson, V. W., St. John, J. A., Hodis, H. N., McCleary, C. A., Stanczyk, F. Z., Shoupe, D., Kono, N., Dustin, L., Allayee, H., Mack, W. J. Tags: Clinical trials Randomized controlled (CONSORT agreement), Class I, Cognitive aging ARTICLE Source Type: research
Self-Administered Lidocaine Gel for Intrauterine Device Insertion in Nulliparous Women: A Randomized Controlled Trial.
CONCLUSION: For nulliparous women, self-administered vaginal lidocaine gel does not reduce pain with IUD insertion, but does decrease pain with tenaculum placement.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT01534520.
PMID: 27500351 [PubMed - as supplied by publisher] (Source: Obstetrics and Gynecology)
Source: Obstetrics and Gynecology - August 4, 2016 Category: OBGYN Authors: Rapkin RB, Achilles SL, Schwarz EB, Meyn L, Cremer M, Boraas CM, Chen BA Tags: Obstet Gynecol Source Type: research
Detectable tenofovir levels in breastfeeding infants of mothers exposed to topical tenofovir.
Abstract
Lactation studies are necessary evaluations of medications for reproductive-age women. We evaluated pharmacokinetics, pharmacodynamics, safety, and adherence profiles associated with 7 days of 1% tenofovir vaginal gel use during lactation. Tenofovir levels (maternal/infant serum, milk) and anti-HIV activity (milk), adverse events (AEs), and adherence were measured for 17 HIV-1-seronegative breastfeeding mother-infant pairs. Tenofovir use was well-tolerated and detected at low levels in maternal serum, milk, and infant serum, but demonstrated no anti-HIV activity in milk.
PMID: 27401570 [Pu...
Source: Antimicrobial Agents and Chemotherapy - July 10, 2016 Category: Microbiology Authors: Noguchi LM, Montgomery ET, Biggio JR, Hendrix CW, Bogen DL, Hillier SL, Dai JY, Piper JM, Marzinke MA, Dezzutti CS, Isaacs SK, Schwartz JL, Watts DH, Beigi RH Tags: Antimicrob Agents Chemother Source Type: research
Efficacy, tolerability and safety of a new medical device, Monurelle Biogel ® vaginal gel, in the treatment of vaginal dryness: a randomized clinical trial in women of reproductive age
Conclusions The present multicentre RCT supports the use of Monurelle Biogel® in women of reproductive age reporting symptoms of vaginal dryness. A positive impact on vaginal health and sexual function was also evident. (Source: European Journal of Obstetrics and Gynecology and Reproductive Biology)
Source: European Journal of Obstetrics and Gynecology and Reproductive Biology - June 17, 2016 Category: OBGYN Source Type: research
[Patient's experience of topical anesthesia by lidocaine vaginal gel for oocyte retrieval].
CONCLUSION: The use of intravaginal lidocaine gel seems an acceptable analgesia alternative during oocyte retrieval.
PMID: 27318637 [PubMed - as supplied by publisher] (Source: Journal de Gynecologie, Obstetrique et Biologie de la Reproduction)
Source: Journal de Gynecologie, Obstetrique et Biologie de la Reproduction - June 14, 2016 Category: OBGYN Authors: Guillaume A, Schuller-Dufour E, Faitot V, Pirrello O, Rongières C, Ohl J, Nisand I, Bettahar K Tags: J Gynecol Obstet Biol Reprod (Paris) Source Type: research
Stated product formulation preferences for HIV pre-exposure prophylaxis among women in the VOICE-D (MTN-003D) study.
CONCLUSIONS: While there was interest in a variety of potential PrEP product formulations, a majority of VOICE-D participants preferred long-acting methods. More research is needed to gain insight into end-users' product formulation preference to inform messaging and market segmentation for different PrEP products and resources to invest in products that target populations are most interested in using.
CLINICAL TRIAL NUMBER: NCT02358616.
PMID: 27247202 [PubMed - in process] (Source: Journal of the International AIDS Society)
Source: Journal of the International AIDS Society - June 3, 2016 Category: Infectious Diseases Tags: J Int AIDS Soc Source Type: research
Efficacy, tolerability and safety of a new medical device, Monurelle Biogel® vaginal gel, in the treatment of vaginal dryness: a randomized clinical trial in women of reproductive age
Conclusions The present multicentre RCT supports the use of Monurelle Biogel® in women of reproductive age reporting symptoms of vaginal dryness. A positive impact on vaginal health and sexual function was also evident. (Source: European Journal of Obstetrics and Gynecology and Reproductive Biology)
Source: European Journal of Obstetrics and Gynecology and Reproductive Biology - June 1, 2016 Category: OBGYN Source Type: research
Coupled gel spreading and diffusive transport models describing microbicidal drug delivery
Publication date: 2 October 2016 Source:Chemical Engineering Science, Volume 152 Author(s): Claire Funke, Kelsey MacMillan, Anthony S. Ham, Andrew J. Szeri, David F. Katz Gels are a drug delivery platform that is being evaluated for application of active pharmaceutical ingredients, termed microbicides, that act topically against vaginal and rectal mucosal infection by sexually transmitted HIV. Despite success in one Phase IIb trial of a vaginal gel delivering tenofovir, problems of user adherence to designed gel application scheduling have compromised results in two other trials. The microbicides field is res...
Source: Chemical Engineering Science - May 27, 2016 Category: Chemistry Source Type: research
Efficacy, tolerability and safety of a new medical device, Monurelle Biogel® vaginal gel, in the treatment of vaginal dryness. A randomized clinical trial in women of reproductive age
To prove the efficacy, tolerability and safety of Monurelle Biogel® (ZP-025) vaginal gel, which contains a purified, dialyzed, lyophilized bovine colostrum, in women of reproductive age suffering from vaginal dryness. (Source: European Journal of Obstetrics, Gynecology, and Reproductive Biology)
Source: European Journal of Obstetrics, Gynecology, and Reproductive Biology - May 24, 2016 Category: OBGYN Authors: Rossella E. Nappi, Chiara Benedetto, Federica Campolo, Silvia Martella, Claudia Tosti, Antonio Cianci, Salvatore Caruso, Secondo Guaschino, Eva Grimaldi, Massimo Bagolan, Marco Sardina Tags: Research Article Source Type: research
The effect of luteal-phase support with vaginal progesterone on pregnancy rates in gonadotropin and clomiphene citrate/intra-uterine insemination cycles in unexplained infertility: A prospective randomised study.
This study implies that luteal-phase support with progesterone has no pronounced beneficial effect on pregnancy rates in either CC/IUI or Gn/IUI cycles in patients with unexplained infertility.
PMID: 27146108 [PubMed - as supplied by publisher] (Source: Journal of Obstetrics and Gynaecology)
Source: Journal of Obstetrics and Gynaecology - May 6, 2016 Category: OBGYN Tags: J Obstet Gynaecol Source Type: research
Biomarkers and biometric measures of adherence to use of ARV-based vaginal rings.
CONCLUSIONS: While some approaches show significant promise over others, it is recommended that a strategy of using complementary biometric and behavioural approaches be adopted to best understand participants' adherence to ARV-based ring products in clinical trials.
PMID: 27144262 [PubMed - in process] (Source: Journal of the International AIDS Society)
Source: Journal of the International AIDS Society - May 6, 2016 Category: Infectious Diseases Tags: J Int AIDS Soc Source Type: research
Biomarkers and biometric measures of adherence to use of ARV-based vaginal rings.
CONCLUSIONS: While some approaches show significant promise over others, it is recommended that a strategy of using complementary biometric and behavioural approaches be adopted to best understand participants' adherence to ARV-based ring products in clinical trials.
PMID: 27142091 [PubMed - in process] (Source: Journal of the International AIDS Society)
Source: Journal of the International AIDS Society - May 6, 2016 Category: Infectious Diseases Tags: J Int AIDS Soc Source Type: research
Safety, efficacy, and tolerability of differential treatment to prevent and treat vaginal dryness and vulvovaginitis in diabetic women.
CONCLUSIONS: The proposed treatment with DermoXEN® Ultracalming Special for diabetics and DermoXEN® Vitexyl vaginal gel exert effective moisturizing and soothing action. Indeed, the aforementioned products have been proven effective for the main gynecological problems of diabetic women.
PMID: 27132409 [PubMed - in process] (Source: Clinical and Experimental Obstetrics and Gynecology)
Source: Clinical and Experimental Obstetrics and Gynecology - May 3, 2016 Category: OBGYN Tags: Clin Exp Obstet Gynecol Source Type: research
Sharing of Investigational Drug Among Participants in the Voice Trial
We describe incidents of product sharing at the Durban clinical research sites conducting the VOICE trial. The Durban sites enrolled 2750 women with 1103 and 1647 participants randomized to the vaginal gel and oral tablet arms respectively. Monthly pill and applicator counts including product assessments were conducted by pharmacists. Discrepancies with product counts prompted discussions with participants. Thirty-two cases of product sharing were identified. Vaginal gels were more commonly shared than oral tablets. Product sharing between study participants and their female friends or relatives living in the same househol...
Source: AIDS and Behavior - May 3, 2016 Category: Infectious Diseases Source Type: research
Combination pod-intravaginal ring delivers antiretroviral agents for HIV prophylaxis: pharmacokinetic evaluation in an ovine model.
Abstract
Pre-exposure prophylaxis (PrEP) against HIV using oral regimens based on the nucleoside reverse transcriptase inhibitor tenofovir disoproxil fumarate (TDF) has been effective to varying degrees in multiple clinical trials, and the CCR5 receptor antagonist maraviroc (MVC) holds potential for complementary efficacy. The effectiveness of HIV PrEP is highly dependent on adherence. Incorporation of the TDF-MVC combination into intravaginal rings (IVRs) for sustained mucosal delivery could increase product adherence and efficacy when compared with oral and vaginal gel formulations. A novel pod-IVR techn...
Source: Antimicrobial Agents and Chemotherapy - April 10, 2016 Category: Microbiology Authors: Moss JA, Butkyavichene I, Churchman SA, Gunawardana M, Fanter R, Miller CS, Yang F, Easley JT, Marzinke MA, Hendrix CW, Smith TJ, Baum MM Tags: Antimicrob Agents Chemother Source Type: research
